HealthyPhase 1NCT05190133
Drug-drug Interaction Study Between UIC201601 and UIC201602
A Phase 1 study testing UIC201602 and co-administration of UIC201601 and UIC201602 and UIC201601 and co-administration of UIC201601 and UIC201602 in people with Healthy, run by Korea United Pharm. Inc..
Trial summary
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- UIC201602 and co-administration of UIC201601 and UIC201602 and UIC201601 and co-administration of UIC201601 and UIC201602
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2016to 17 Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
- Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
- Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
- Subjects able to read and understand a written informed consent, and willing to participate in the study.
Who cannot join
- Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
- Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
- Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
- Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
- Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
- etc.
About this study
Official title: An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201601 and UIC201602 in Healthy Male Volunteers
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- UIC201602 and co-administration of UIC201601 and UIC201602, UIC201601 and co-administration of UIC201601 and UIC201602
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UIC201602 and co-administration of UIC201601 and UIC201602Drug
- UIC201602 4 Cap/day for 14 days
- Wash out 21 days
- UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days
UIC201601 and co-administration of UIC201601 and UIC201602Drug
- UIC201601 4 Tab/day for 7 days
- Wash out 14 days
- UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: UIC201602 and co-administration of UIC201601 and UIC201602 |
| Treatment B | Experimental | Not described Receives: Drug: UIC201601 and co-administration of UIC201601 and UIC201602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetics(AUCss,τ) of UIC201602
Area under the serum drug concentration-time curve within a dosing interval at steady state
Measured: 0 hour to 24 hours after Day 14 and Day 49 administration
Plasma pharmacokinetics(Css,max) of UIC201602
Maximum concentration of drug in serum at steady state
Measured: 0 hour to 24 hours after Day 14 and Day 49 administration
Plasma pharmacokinetics(AUCss,τ) of UIC201601
Area under the serum drug concentration-time curve within a dosing interval at steady state
Measured: 0 hour to 24 hours after Day 7 and Day 35
Plasma pharmacokinetics(Css,max) of UIC201601
Maximum concentration of drug in serum at steady state
Measured: 0 hour to 24 hours after Day 7 and Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start28 May 2016
- Primary completion17 Aug 2016
- Study completion17 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea United Pharm. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janghee Hong, M.D.,Ph.D., Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190133
- Sponsor's protocol ID
- KUP-UI018-101
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201601 and UIC201602 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05190133
- Acronym / sponsor ID
- KUP-UI018-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Korea United Pharm. Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2016 (actual)
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- 17 Aug 2016 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: UIC201602 and co-administration of UIC201601 and UIC201602 |
| Treatment B | Experimental | Drug: UIC201601 and co-administration of UIC201601 and UIC201602 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
- Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
- Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
- Subjects able to read and understand a written informed consent, and willing to participate in the study.
Key exclusion criteria (6 listed)
- Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
- Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
- Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
- Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
- Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UIC201602 and co-administration of UIC201601 and UIC201602* UIC201602 4 Cap/day for 14 days * Wash out 21 days * UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days | Drug | Treatment A |
| UIC201601 and co-administration of UIC201601 and UIC201602* UIC201601 4 Tab/day for 7 days * Wash out 14 days * UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days | Drug | Treatment B |
Primary outcome
Plasma pharmacokinetics(AUCss,τ) of UIC201602
Time frame: 0 hour to 24 hours after Day 14 and Day 49 administration
Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(Css,max) of UIC201602
Time frame: 0 hour to 24 hours after Day 14 and Day 49 administration
Maximum concentration of drug in serum at steady state
Plasma pharmacokinetics(AUCss,τ) of UIC201601
Time frame: 0 hour to 24 hours after Day 7 and Day 35
Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(Css,max) of UIC201601
Time frame: 0 hour to 24 hours after Day 7 and Day 35
Maximum concentration of drug in serum at steady state
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janghee Hong, M.D.,Ph.D. principal investigator
Chungnam National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UIC201602 and co-administration of UIC201601 and UIC201602 and UIC201601 and co-administration of UIC201601 and UIC201602 in people with Healthy, run by Korea United Pharm. Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma pharmacokinetics(AUCss,τ) of UIC201602 (time frame: 0 hour to 24 hours after Day 14 and Day 49 administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.